The endpoint for this study will be measured as follows: assessment of the effectiveness of cryoablation associated with palliation of pain in subjects with metastatic bone cancer by measuring the average difference of pre- and posttreatment worst pain in 24 hours from baseline to 24 hour, 1, 4, 12, and 24 week follow-up intervals as measured on the numeric 0 to 10 Brief Pain Inventory (BPI) scale.

If the first cryoablation procedure effectively relieves pain but the relief wears off over time and the pain becomes unbearable, a second procedure may be performed. The number of repeat cryoablation treatments will be recorded.

The number of subjects (percentage) who are able to reduce analgesic medications from baseline to 24 hours, 1, 4, 12, and 24 weeks after cryoablation will be recorded.

Time to maximal palliation of pain after cryoablation [ Time Frame: 24 weeks post-cryoablation ] [ Designated as safety issue: No ]

The difference in pain scores will be assessed from baseline to follow-up intervals after cryoablation will be analyzed. The interval indicating the most relief from pain will be compared across subjects.

The safety endpoint for this study is to assess the incidence and severity of intra-operative events, post operative adverse events, serious adverse events and unanticipated adverse device effects related to the cryoablation procedure.

All subjects will have cryoablation on one or two painful metastatic bone tumors.

Procedure: Cryoablation

For cryoablation in the palliation of painful bone metastases, subject preparation, anesthesia, intra-operative monitoring, and postoperative management are identical to those of standard cryoablation routinely performed at all clinical centers participating in this study and are at the discretion of the investigator.

Other Names:

Cryotherapy

Cryosurgery

Visual-ICE Cryoablation System

SeedNet Cryoablation System

PresIce Cryoablation System

IceRod Cryoablation Needle

IceRod PLUS Cryoablation Needle

IceEDGE 2.4 Cryoablation Needle

IceSeed Cryoablation Needle

IceSphere Cryoablation Needle

Detailed Description:

Patients with painful bone metastases who meet the eligibility criteria and who have been determined to be an appropriate candidate for cryoablation therapy will be offered enrollment into the study. Cryoablation is the process of destroying tissue by the application of extremely cold temperatures. Galil Medical Cryoablation Systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), Ears-Nose-Throat (ENT), gynecology, oncology (cancer), proctology (colon/rectal) and urology (kidney).

Patients agreeing to participate will read and sign an informed consent form and thus become subjects in the study. Treatment will be performed using a Galil Medical cryoablation system and Galil Medical cryoablation needles. Subjects will be followed for up to 24 weeks (6 months) for palliation of pain, quality of life and analgesic usage. Baseline and follow-up data will be collected for each subject via a web-based electronic data collection tool.

Current analgesic therapies have failed OR the subject is experiencing intolerable side effects

Unremitting pain that resulted in a return visit to the oncologist. The 'worst pain' in the last 24 hours must be reported to be 4 or above on a scale of 0 (no pain) to 10 (pain as bad as subject can imagine) despite pharmaceutical pain management

Pain must be from one or two painful metastatic sites in the bone that is amenable to cryoablation with CT or MRI (additional less painful metastatic sites may be present)

Pain from the reported one or two metastatic sites must correlate with an identifiable tumor on CT, MRI, or ultrasound (US) imaging

Tumors must be suitable for cryoablation

Cryoablation should be performed within 14 days of baseline evaluations

Stable use of hormonal therapy (no changes within 4 weeks prior to the cryoablation procedure)

Stable use of pain medications (no changes within 2 weeks prior to the cryoablation procedure)

No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up

If taking antiplatelet or anticoagulation medication, it must be able to be discontinued prior to the procedure for an appropriate amount of time (e.g., aspirin, ibuprofen, low molecular weight heparin preparations)

Clinically suitable for cryoablation therapy

Exclusion Criteria:

Leukemia, lymphoma, and myeloma

Tumor involves a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone

Anticipated treatment of the index tumor that would require iceball formation within 1.0 cm of the spinal cord, brain, other critical nerve structure, large abdominal vessel such as the aorta or inferior vena cava, bowel, or bladder

Surgery at the tumor site or surgery involving the cryoablation-treated tumor (index tumor)

Index tumor involves the skull (treatment of other painful tumors in subjects with skull tumors is not excluded)

Concurrent participation in other experimental studies that could affect the primary endpoint

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461265